Trial | NCT00552565  Report issue

Title

Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    verapamil ...

  • Study Participants

    711
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.
We have fulfilled our enrollment requirements for this study.

This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.

Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).
Study Started
Sep 30
2007
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Jun 11
2009
Estimate

Drug Rezular 15mg

Oral Tablets

Drug Placebo

placebo

Drug Rezular

Rezular 37.5mg 3xday up to 12 weeks

Drug Rezular

Rezular 75mg 3xday up to 12 weeks

1 Placebo Comparator

2 Experimental

Rezular 37.5mg Experimental

Rezular - 75mg Experimental

Criteria 

Inclusion Criteria:

fulfilling Rome III criteria for IBS-D

Exclusion Criteria:

major cardiovascular disease
psychiatric illness except mild or moderate depression
pregnancy
presence of other GI disease that could explain IBS-like symptoms
history of major gastric, hepatic, pancreatic or intestinal surgery or perforation
No Results Posted